Medical Writer

SystImmune, Inc.; Princeton (NJ); On-site; USD 80,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Systimmune, located in Princeton, NJ, is seeking a Medical Writer to manage clinical documentation including study protocols and reports. This role requires a Master's degree in life sciences and 3-4 years of experience in pharma.

The successful candidate will ensure documents meet regulatory standards and maintain high quality. The hiring pay range is $80,000 – $130,000 annually, and Systimmune offers a comprehensive benefits package.

Qualifications

• 3-4 years of experience as a medical writer in the pharmaceutical industry.
• Proven experience writing protocols, CSRs, ISE, ISS, and Clinical Overview.
• Knowledge of drug development and regulatory requirements.

Responsibilities

• Manage and oversee medical writing projects including clinical study protocols.
• Write and edit high-quality clinical documentation for regulatory submission.
• Track clinical documentation milestones and ensure quality standards.

Skills

Excellent writing skills

Effective communication skills

Organizational skills

Knowledge of FDA and ICH guidelines

Skilled in clinical data interpretation

Interpersonal skills

Education

Master's degree in life sciences or PhD with 1 year experience

Job description

Located in Redmond, WA, SystImmune, Inc. is a biopharmaceutical company focused on treating cancer through developing novel therapeutic multi‑specific antibodies and antibody‑drug conjugates (ADCs).

Position Summary

The medical writer will be responsible for the management and oversight of assigned medical writing projects, including clinical study protocols and reports, investigational new drug applications (INDs), investigator brochures, reviewing informed consent forms and regulatory briefing materials. They will be accountable for ensuring that all documents are written according to established templates and guidance, and that they are of the highest quality with respect to scientific content, organization, accuracy, regulatory guidelines, clarity of presentation, and structure.

Key Responsibilities

1. Write, edit and/or manage the production of high‑quality clinical documentation including clinical study protocols, synopses, and clinical study reports for submission to regulatory authorities in support of marketing applications and BLAs.
2. Act as a member of clinical trial teams.
3. Follow and track clinical documentation milestones.
4. Write/edit other strategic documents as required.

Required Qualifications

• Master's degree in a life sciences discipline or at least 3 to 4 years of experience as a medical writer in the pharmaceutical industry; PhD with at least 1 year experience as a medical writer in the pharmaceutical industry.
• Excellent writing and effective communication skills.
• Proven interpersonal, organizational and problem‑solving skills in a matrix management environment.
• Knowledge of FDA and ICH guidelines.
• Skilled in clinical data interpretation.
• Proven experience writing/supporting major documents (e.g., protocols, CSRs, ISE, ISS, and Clinical Overview).

Preferred Qualifications

• Knowledge of drug development and regulatory requirements to guide document organization.
• Project management experience including the use of negotiation and influence to ensure document timelines are met while maintaining high quality.

The hiring pay range for this position is $80,000 – $130,000 per year based on skills, education, and experience relevant to the role.

SystImmune offers a comprehensive benefits package.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.